NCT00719238

Brief Summary

The long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
Last Updated

July 21, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

July 17, 2008

Last Update Submit

July 18, 2008

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Sugar intake

    3 months post partum

Secondary Outcomes (1)

  • mutans streptococci levels

    3 months post partum

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Nutrition plus education

2

ACTIVE COMPARATOR
Behavioral: Education only

Interventions

Nutrition plus educationBEHAVIORAL

Nutritional instruction in small groups plus education

1
Education onlyBEHAVIORAL

Educational video and pamphlets

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or over;
  • Pregnant
  • High S. mutans levels

You may not qualify if:

  • Younger than 18;
  • Other health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Nutritional StatusEducational Status

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Susan Reisine, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

July 21, 2008

Record last verified: 2008-07

Locations

US(1)